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Merge Healthcare, Inc. recalls Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the H
Recalled November 5, 2014 · FDA recall Z-0143-2015 · Merge Healthcare
Hazard
It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value. It is also possible that if using the pulse rate of the SpO2 finger clip to calculate the patient's heart rate, it too may be subject to displaying a stale value. · FDA Class II
Units
52
Sold at
Nationwide Distribution including the states of AZ, CA, FL, IL, IA, MA, MO, OH, SC, TN, and WI.
Description
It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value. It is also possible that if using the pulse rate of the SpO2 finger clip to calculate the patient's heart rate, it too may be subject to displaying a stale value.
Product
Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC. The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/1 IOV.
Manufacturer(s)
Merge Healthcare, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →